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ISO 80369-7:2021
Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications- 발행일 : 2021-05-04
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 210 : Quality management and corresponding general aspects for medical devices |
|---|---|
| 적용범위 | This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors. NOTE 1 See Annex A. NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa. This document does not specify requirements for themedical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories. This document does not specify requirements for the following small-bore connectors, which are specified in other documents: - haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and applicable portion of ISO 8638 [ 6] referencing blood compartment ports); - haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]); - infusion system closure piercing connectors (ISO 8536-4 [4]). NOTE 3 Manufacturers are encouraged to incorporate thesmall-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included. NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document. |
| 국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
| 페이지수 | 47 |
| Edition | 2 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 80369-7:2021상세보기 | Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications | 2021-05-04 | 표준 |
| 2 | ISO 80369-7:2016상세보기 | Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications | 2016-10-14 | 구판 |
관련상품
- ISO/DIS 80369-2 - Small bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for breathing systems and driving gases applications
- ISO 80369-3:2016/DAmd 2 - Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications — Amendment 2: .
- ISO 80369-3:2016/DAmd 1 - Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications — Amendment 1: .
- ISO/FDIS 80369-1 - Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
- ISO 80369-6 - Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neural applications
다른 사람이 함께 구입한 상품
- ISO 80369-20:2015 - Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods
- ISO 80369-1:2018 - Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
- ASTM F2213-17 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- ASTM F2052-21 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- KS P ISO 11040-6 - 사전충진형 주사기 ─ 제6부: 주사기 플라스틱 외통
추천 상품
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- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
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